Lung Cancer
Conditions
Brief summary
The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of North and East Manchester, which has high rates of lung cancer. One measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. In addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. We will also see if these samples can help with the interpretation of CT scans. One of the problems with lung cancer CT screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.
Interventions
DIAGNOSTIC_TESTLung Cancer Screening
The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
DIAGNOSTIC_TESTBiomarkers
This will explore the role of biomarkers for the early detection of lung cancer. These include circulating nucleic acids, circulating proteins, circulating tumour cells and inflammatory markers.
Sponsors
Cancer Research UK
University of Manchester
Manchester University NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Inclusion criteria
Main data study: Inclusion Criteria: \- Any individual attending the Manchester Lung Health service who has a lung health check as they meet the service inclusion
Exclusion criteria
(see below): Manchester Lung Health service inclusion criteria: * Age 55-80 * Ever smoker * Registered with a GP in the North or East Manchester area Manchester Lung Health service
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of the Manchester lung health check service | Over 3 years to determine long term outcomes from screening | The overall uptake will be assessed and analysed according to age, sex, smoking status, ethnicity and socio economic status. |
| Evaluation of biomarkers | Over 3 years to determine long term outcomes from screening | Sensitivity and specificity of a biomarker or panel of biomarkers to detect early stage lung cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of screening numbers required to detect lung cancer | Over 3 years to determine long term outcomes from screening | Number needed to screen to detect one lung cancer according to lung cancer risk (as calculated by PLCOM2012). |
| Treatment for lung cancer related to screening service | Over 3 years to determine long term outcomes from screening | Treatment of lung cancers in screening and outside of screening during the course of the service. |
| Comparison between cohort and those residents diagnosed in north and east manchester | Over 3 years to determine long term outcomes from screening | Lung cancer stage in the screened cohort compared to lung cancers diagnosed in residents of N+EM outside of the screening service. |
| Diagnosis route for lung cancer related to screening service | Over 3 years to determine long term outcomes from screening | Route to diagnosis of lung cancers in screening and outside of screening during the course of the service. |
| False positive rates | Over 3 years to determine long term outcomes from screening | False positive rates in those undergoing LDCT screening. |
| False negative rates | Over 3 years to determine long term outcomes from screening | False negative rates in those undergoing LDCT screening. |
| Rates of investigation of benign disease | Over 3 years to determine long term outcomes from screening | Rates of investigation of benign disease in those undergoing LDCT screening. |
| Benign resection rate in participants | Over 3 years to determine long term outcomes from screening | Benign resection rate in participants for those that have undergoing LDCT screening. |
| Histological subtype for lung cancer related to screening service | Over 3 years to determine long term outcomes from screening | Histological subtype of lung cancers in screening and outside of screening during the course of the service. |
| Recall rates | Over 3 years to determine long term outcomes from screening | Recall rates in those undergoing LDCT screening. |
| Resection rates generated from screening | Over 3 years to determine long term outcomes from screening | Resection rates generated from screening including incidental findings. |
| Investigations generated from screening | Over 3 years to determine long term outcomes from screening | Investigations generated from screening including incidental findings. |
| Adverse events generated from screening | Over 3 years to determine long term outcomes from screening | Adverse events generated from screening including incidental findings. |
| Assessment of the British Thoracic Society pulmonary nodule guidelines | Over 3 years to determine long term outcomes from screening | Assessment of performance of the BTS pulmonary nodules guideline in the setting of screening service. |
| Smoking prevalence | Over 3 years to determine long term outcomes from screening | Smoking prevalence and amount at the start and end of screening. |
| Undiagnosed airflow obstruction | Over 3 years to determine long term outcomes from screening | Prevalence of undiagnosed airflow obstruction in the screened population. |
| Coronary artery calcification | Over 3 years to determine long term outcomes from screening | Prevalence of coronary artery calcification and QRISK2 score. |
| Interval cancers | Over 3 years to determine long term outcomes from screening | Interval cancers in those undergoing LDCT screening. |
| Screening adherence | Over 3 years to determine long term outcomes from screening | overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status). |
Countries
United Kingdom
Contacts
Primary ContactPhilip Crosbie
Backup ContactSara Waplington
Outcome results
None listed